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Zero Positive End-expiratory Pressure Before Emergence Prevents Postoperative Atelectasis.

Primary Purpose

Atelectasis, Oxygenation

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ZEEP
PEEP
Sponsored by
Region Västmanland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis focused on measuring Atelectasis, Oxygenation, Positive end-expiratory pressure, Mechanical ventilation, General anesthesia, Computed tomography

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiology (ASA) class I-II
  • Non-abdominal day case surgery under general anesthesia

Exclusion Criteria:

  • Body mass index (BMI) ≥30 kg/m2
  • Arterial oxygen saturation (SpO2) breathing air <95 %
  • Chronic Obstructive Pulmonary Disease (COPD) or symptomatic asthma
  • Symptomatic congestive heart failure
  • Ischemic heart disease
  • Hemoglobin <100 g/L
  • Active smokers
  • Active smokers and ex-smokers with a history of more than 6 pack years.
  • Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).

Sites / Locations

  • Department of Anaesthesia and Intensive Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ZEEP at awakening

PEEP at awakening

Arm Description

Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) until start of emergence preoxygenation. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. First CT scan after completion of surgery, before emergence. After the first CT scan and immediately before start of emergence preoxygenation, this group will have the PEEP exchanged for zero PEEP (ZEEP). ZEEP will remain until the study subjects are extubated. Second CT scan approx. 30 min after extubation.

Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) even after start of emergence preoxygenation. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. First CT scan after completion of surgery, before emergence. After the first CT scan, this group will have PEEP remained until the study subjects are extubated. Second CT scan approx. 30 min after extubation.

Outcomes

Primary Outcome Measures

Change in atelectasis area
Atelectasis area as studied by computed tomography.

Secondary Outcome Measures

Change in oxygenation
Arterial blood samples will be collected for measurement of arterial oxygen partial pressure.

Full Information

First Posted
November 8, 2017
Last Updated
September 4, 2018
Sponsor
Region Västmanland
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1. Study Identification

Unique Protocol Identification Number
NCT03351946
Brief Title
Zero Positive End-expiratory Pressure Before Emergence Prevents Postoperative Atelectasis.
Official Title
Zero Positive End-expiratory Pressure Applied Before Emergence Preoxygenation Prevents Postoperative Atelectasis - a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Västmanland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A study on healthy patients undergoing anesthesia for non-abdominal surgery - evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure on the amount of atelectasis in the early postoperative period.
Detailed Description
Positive end-expiratory pressure (PEEP) is often used during mechanical ventilation to preserve end-expiratory lung volume. After emergence and extubation, this volume will diminish instantly. Some patients will have difficulties to restore functional residual capacity (FRC) during the early phase of recovery. If routine high FIO2 has been delivered together with maintained PEEP prior to extubation, several important prerequisites are established for the development of postoperative atelectasis. The investigators hypothesize that establishing zero positive end-expiratory pressure (ZEEP) immediately prior to emergence preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal areas of the lungs, and thereby prevent postoperative atelectasis formation. This randomized controlled study will study patients undergoing non-abdominal day case surgeries under general anesthesia. The patients in the two study groups will receive mechanical ventilation with identical settings, comprising low TV, moderate PEEP, and no RM. At the end of surgery, the lungs will be examined by CT, and any atelectasis areas will be calculated. Randomization will occur after the first CT. The patients will be allocated to zero PEEP (ZEEP) or maintained PEEP during emergence preoxygenation and extubation. Importantly, the intervention group will have ZEEP established while still having low ETO2 levels, prior to any preoxygenation. The study subjects will be examined with CT no.2 approximately thirty min after extubation. Primary endpoint measure will be atelectasis area as a percentage of total lung area. Blood gases will be collected for comparison of oxygenation as a secondary outcome measure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Oxygenation
Keywords
Atelectasis, Oxygenation, Positive end-expiratory pressure, Mechanical ventilation, General anesthesia, Computed tomography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Sealed envelopes.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZEEP at awakening
Arm Type
Active Comparator
Arm Description
Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) until start of emergence preoxygenation. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. First CT scan after completion of surgery, before emergence. After the first CT scan and immediately before start of emergence preoxygenation, this group will have the PEEP exchanged for zero PEEP (ZEEP). ZEEP will remain until the study subjects are extubated. Second CT scan approx. 30 min after extubation.
Arm Title
PEEP at awakening
Arm Type
Active Comparator
Arm Description
Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) even after start of emergence preoxygenation. Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure. First CT scan after completion of surgery, before emergence. After the first CT scan, this group will have PEEP remained until the study subjects are extubated. Second CT scan approx. 30 min after extubation.
Intervention Type
Procedure
Intervention Name(s)
ZEEP
Other Intervention Name(s)
Device: Ventilatory setting ZEEP
Intervention Description
Zero positive end-expiratory pressure (ZEEP) during emergence preoxygenation and awakening.
Intervention Type
Procedure
Intervention Name(s)
PEEP
Other Intervention Name(s)
Device: Ventilatory setting PEEP
Intervention Description
Positive end-expiratory pressure remains during emergence preoxygenation and awakening and until the study subject is extubated.
Primary Outcome Measure Information:
Title
Change in atelectasis area
Description
Atelectasis area as studied by computed tomography.
Time Frame
Within 3 hours from induction of anesthesia. First CT after surgery, before emergence. Second CT approx 25 min after extubation. Study complete after that, no further CT.
Secondary Outcome Measure Information:
Title
Change in oxygenation
Description
Arterial blood samples will be collected for measurement of arterial oxygen partial pressure.
Time Frame
Within 3 hours from induction of anesthesia. First blood gas after surgery, before emergence. Second approx 25 min after extubation. Study complete after that, no further blood gases.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiology (ASA) class I-II Non-abdominal day case surgery under general anesthesia Exclusion Criteria: Body mass index (BMI) ≥30 kg/m2 Arterial oxygen saturation (SpO2) breathing air <95 % Chronic Obstructive Pulmonary Disease (COPD) or symptomatic asthma Symptomatic congestive heart failure Ischemic heart disease Hemoglobin <100 g/L Active smokers Active smokers and ex-smokers with a history of more than 6 pack years. Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Edmark, M.D., Ph.D.
Organizational Affiliation
Region Västmanland
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anaesthesia and Intensive Care
City
Köping
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Please email request to the study principal investigator.
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by a review panel at the Center for Clinical Research, Västerås. Requestors will be required to sign a data acess agreement.

Learn more about this trial

Zero Positive End-expiratory Pressure Before Emergence Prevents Postoperative Atelectasis.

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